Relapsed/Refractory Multiple MyelomaPhase 1NCT07558915
A Study to Evaluate RO7851624 in Participants With Relapsed/Refractory Multiple Myeloma (RRMM)
A Phase 1 study testing RO7851624 in people with Relapsed/Refractory Multiple Myeloma, run by Genentech, Inc. at 1 site in Australia.
Trial summary
This study will evaluate safety, pharmacokinetics (PK), clinical activity and pharmacodynamics (PD) of RO7851624 in participants with RRMM who are triple-class exposed (treated with proteasome inhibitors [PIs], immunomodulators [IMiDs], and anti-cluster of differentiation 38 [anti-CD38] monoclonal antibodies), and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Relapsed/Refractory Multiple Myeloma
- What is being tested?
- RO7851624
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteAustralia
- Study dates
- 23 Jun 2026to 1 Oct 2031
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
- Life expectancy of at least 12 weeks.
- Diagnosis of multiple myeloma per International Myeloma Working Group (IMWG) criteria.
- Measurable disease.
Who cannot join
- Treatment with any chemotherapeutic agent, or treatment with any other anti-cancer agent (investigational or otherwise) with insufficient washout prior to first dose of study treatment.
- Autologous stem cell transplant (SCT) with insufficient time prior to first dose of study treatment.
- Prior allogeneic SCT.
- Prior solid organ transplantation.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Reference Study ID Number: GO46140 https://forpatients.roche.com/ No attachments to email below. contact
Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry contact
Australia1 site, 1 recruiting
- Recruiting
Peter MacCallum Cancer Center
Parkville, Victoria, 3052
About this study
Official title: An Open-Label, Multicenter, Phase Ia/b Study Evaluating the Safety and Pharmacokinetics of RO7851624 in Patients With Relapsed/Refractory Multiple Myeloma
This study will evaluate safety, pharmacokinetics (PK), clinical activity and pharmacodynamics (PD) of RO7851624 in participants with RRMM who are triple-class exposed (treated with proteasome inhibitors [PIs], immunomodulators [IMiDs], and anti-cluster of differentiation 38 [anti-CD38] monoclonal antibodies), and have limited remaining standard treatment options due to refractoriness, intolerance, or multiple prior therapies.
- Conditions
- Relapsed/Refractory Multiple Myeloma
- Being tested
- RO7851624
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RO7851624Drug
Participants will receive RO7851624 as per the schedule described in the protocol.
| Study group | Role | What they receive |
|---|---|---|
| RO7851624 | Experimental | Participants will receive RO7851624 in a dose escalation stage followed by a dose expansion stage. Receives: Drug: RO7851624 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With Adverse Events (AEs)
Measured: Up to approximately 2 years
Secondary outcomes (10)
Serum Concentration of RO7851624
Measured: Up to approximately 2 years
Objective Response Rate (ORR)
Measured: Up to approximately 2 years
Complete Response (CR) Rate/ Stringent Complete Response (sCR) Rate)
Measured: Up to approximately 2 years
Rate of Very Good Partial Response (VGPR) Rate or Better
Measured: Up to approximately 2 years
Progression-Free Survival (PFS)
Measured: Up to approximately 2 years
Duration of Response (DOR)
Measured: Up to approximately 2 years
Time to First Response
Measured: Up to approximately 2 years
Time to Best Response
Measured: Up to approximately 2 years
Percentage of Participants With Anti-Drug Antibodies (ADAs) Against RO7851624 at Baseline and During the Study
Measured: Baseline, up to approximately 2 years
Recommended Dose and Regimen of RO7851624
Measured: Up to approximately 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2026
- Study start23 Jun 2026
- Primary completion1 Jul 2030 (estimated)
- Study completion1 Oct 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapsed/Refractory Multiple MyelomaStudies of the same condition, open and under way.
- More trials run by Genentech, Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Genentech, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07558915
- Sponsor's protocol ID
- GO46140
- Status last verified
- Oct 2026
- First submitted
- 24 Apr 2026
- Last updated
- 9 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Multicenter, Phase Ia/b Study Evaluating the Safety and Pharmacokinetics of RO7851624 in Patients With Relapsed/Refractory Multiple Myeloma
- ClinicalTrials.gov ID
- NCT07558915
- Acronym / sponsor ID
- GO46140
- Conditions
- Relapsed/Refractory Multiple Myeloma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Genentech, Inc.Industry (pharma, biotech, devices)
- Study start
- 23 Jun 2026 (actual)
- Primary completion
- 1 Jul 2030 (estimated)
- Study completion
- 1 Oct 2031 (estimated)
- First posted
- 30 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will evaluate safety, pharmacokinetics (PK), clinical activity and pharmacodynamics (PD) of RO7851624 in participants with RRMM who are triple-class exposed (treated with proteasome inhibitors [PIs], immunomodulators [IMiDs], and anti-cluster of differentiation 38 [anti-CD38] monoclonal antibodies), and have limited remaining standard treatment options due to refractoriness, intolerance, or multiple prior therapies.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| RO7851624 | Experimental | Drug: RO7851624Participants will receive RO7851624 in a dose escalation stage followed by a dose expansion stage. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
- Life expectancy of at least 12 weeks.
- Diagnosis of multiple myeloma per International Myeloma Working Group (IMWG) criteria.
- Measurable disease.
Key exclusion criteria (4 listed)
- Treatment with any chemotherapeutic agent, or treatment with any other anti-cancer agent (investigational or otherwise) with insufficient washout prior to first dose of study treatment.
- Autologous stem cell transplant (SCT) with insufficient time prior to first dose of study treatment.
- Prior allogeneic SCT.
- Prior solid organ transplantation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RO7851624Participants will receive RO7851624 as per the schedule described in the protocol. | Drug | RO7851624 |
Primary outcome
Percentage of Participants With Adverse Events (AEs)
Time frame: Up to approximately 2 years
10 secondary outcomes
Serum Concentration of RO7851624
Time frame: Up to approximately 2 years
Objective Response Rate (ORR)
Time frame: Up to approximately 2 years
Complete Response (CR) Rate/ Stringent Complete Response (sCR) Rate)
Time frame: Up to approximately 2 years
Rate of Very Good Partial Response (VGPR) Rate or Better
Time frame: Up to approximately 2 years
Progression-Free Survival (PFS)
Time frame: Up to approximately 2 years
Duration of Response (DOR)
Time frame: Up to approximately 2 years
Time to First Response
Time frame: Up to approximately 2 years
Time to Best Response
Time frame: Up to approximately 2 years
Percentage of Participants With Anti-Drug Antibodies (ADAs) Against RO7851624 at Baseline and During the Study
Time frame: Baseline, up to approximately 2 years
Recommended Dose and Regimen of RO7851624
Time frame: Up to approximately 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2026.
- Please use this form to submit your questions for a faster response: https://www.gene.com/contact-us/submit-medical-inquiry. Do not include or attach any medical records when emailing or completing the form. A nurse will respond within 24 business hours.Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Reference Study ID Number: GO46140 https://forpatients.roche.com/ No attachments to email below. contact
Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry contact
Clinical Trials study director
Hoffmann-La Roche
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing RO7851624 in people with Relapsed/Refractory Multiple Myeloma, run by Genentech, Inc. at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Reference Study ID Number: GO46140 https://forpatients.roche.com/ No attachments to email below. (888-662-6728 (U.S. and Canada), global-roche-genentech-trials@gene.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants With Adverse Events (AEs) (time frame: Up to approximately 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2026.